How we orchestrate clinical trials to deliver hope for patients

For many people, clinical trials offer hope and the possibility of a healthier future. Bringing a medicine from concept to patient is a monumental undertaking. It's a journey fueled by scientific innovation but made possible by meticulous execution.

At Bristol Myers Squibb (BMS), our mission is clear: to discover, develop and deliver innovative medicines that address serious diseases. Clinical trials are a key component of this commitment, and in 2025, we progressed more than 300 BMS-sponsored clinical trials involving approximately 165 clinical assets for more than 74,000 patients around the world. Our Product Development and Supply (PDS) organization oversees the journey of our medicines, from development to delivery.

Orchestrating a clinical trial

Clinical trials are complex and require careful planning and flawless execution. PDS acts like the conductor of an orchestra, coordinating many moving parts to ensure everything runs smoothly in close partnership with teams in clinical development. This includes adjusting supply availability to accommodate changes in patient enrollment around the world, overseeing the manufacturing and global distribution of medicines, and addressing special requirements, like ensuring that after completing a trial, patients can continue to receive the product before it is formally approved by regulatory authorities.

PDS collaborates with other teams to keep the process on track, making sure treatments arrive on time and data is reported accurately.

Supplying the steady beat of discovery

Within PDS, the Global Supply Chain (GSC) team is the central connector, ensuring critical medicines reach the right patient, at the right time, across the globe.

To manage and plan for the many complexities of a clinical trial, the Clinical Supply Chain team uses Interactive Response Technology (IRT). This system randomizes patients, determines which medicines to dispense and ensures supplies are available at sites worldwide. IRT acts like a songbook for an orchestra, laying out the plan and keeping everyone in sync.

Using IRT, the GSC team supports approximately 550 studies across more than 250 purpose-built clinical study IRT systems, as well as over 300 Investigator Sponsored Research (ISR) studies at more than 11,000 trial sites in 60 countries. Logistically, this requires the team to orchestrate a complex rhythm, synchronizing approximately 85,000 shipments with individual patient visits and specific protocol requirements. The team constantly adapts to changes — from sudden study accelerations and expansions to new countries to unpredictable external factors such as geopolitical events, severe weather or travel restrictions — to make sure patients aren’t left waiting.

"Global Supply Chain is an instrumental partner in planning and executing clinical trials, both helping to accelerate the pipeline and ensure optimal supply. Driven by purpose, our passionate team works with precision, speed and quality to deliver hope to patients waiting for treatment,” says Pádraig Keane, senior vice president, Global Supply Chain.

Agility and innovation in action

The Product Development (PD) team within PDS plays a pivotal role in creating innovative formulations and delivery systems that ensure investigational medicines reach patients in clinical trials. By designing products with patient needs and trial requirements in mind, PD enables consistent treatment experiences. Despite external challenges, from changing regulations to global events, the team remains focused on delivering medicines that meet both patient needs and business goals – ensuring trial outcomes are driven by clinical factors, not product variability.

Manisha Desai, senior vice president, Product Development, sheds light on the unique complexities of early-stage development: "Complexity is increasing at an unprecedented pace, and any lack of timely information flow creates major execution barriers. Yet, the PD team rises to meet these challenges head-on by designing products so that no matter where in the world they’re shipped, they maintain quality.”

The PD team continuously innovates to remove barriers patients face during treatment. For example, when frequent dosing resulted in an adherence challenge for patients, the team reformulated a product to reduce the pill burden for patients, helping patients maintain a sense of normalcy. By tailoring innovations to the specific needs of patient populations, PD strengthens the overall clinical trial and real-world experience.

Quality throughout it all

At BMS, an unwavering commitment to quality and patient safety is at the foundation of our work, including clinical trials.  This commitment spans from product manufacturing to the oversight of study conduct, ensuring the rights, safety and well‑being of participants and the integrity and reliability of clinical data. It is particularly critical when navigating the unique challenges of maintaining consistent product quality across multiple and often small batches that can be required in clinical trials.

From the earliest stages of manufacturing through protocol execution, investigational site oversight and ultimately to the moment a patient receives their medication, our approach to risk management is structured, proactive and ongoing — seamlessly integrating regulatory compliance, operational flexibility and digital technologies to safeguard both our products and our trials. “Quality is non‑negotiable. Every step is meticulously controlled to protect patients and build trust in the data and treatments we deliver,” says Paul Houri, chief quality officer and senior vice president.

Driving hope forward: The PDS commitment

BMS’ PDS organization translates scientific promise into real progress for patients. Our passion to transform lives is grounded in deep scientific expertise and global innovation. From product development to sustainable supply chains, we are reimagining how life-changing medicines are created, made and delivered. With unwavering dedication, we keep the melody of hope alive — accelerating breakthroughs and delivering essential medicines to those who need them most.